Younger hip patients often need revision of their hip replacement due to wear and loosening. Newer concepts (resurfacing and large head total hip replacement) with articulation surfaces in metal may reduce the wear, increase the longevity of the implant and give an improved function. The possible downside is that these concepts releases metal debris to the body. The investigators wish to see if the newer interventions are a clinical improvement compared to standard. The investigators also wish to investigate the extent of metal released to the body and any effect on the immune system. Finally the investigators wish to investigate the stability of these new implants and their ability to preserve the bone around the implant. The investigators hypothesis is: That the metal on metal articulations will not have better clinical outcomes than standard The resurfacing implant is expected to preserve the bone of the upper femoral bone. The implants are expected to be stabile within the first year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
posterolateral incision
posterolateral incision
posterolateral incision
posterolateral incision
Naestved Hospital Dept. of orthop. surg.
Næstved, Denmark
Odense University hospital
Odense, Denmark
Range of motion
range of motion in the hip joint evaluated by goniometer
Time frame: Up to two months before surgery
Range of motion
Range of motion of the hip joint
Time frame: 8 weeks +/- 1 week
Range of motion
range of motion in the hip joint
Time frame: 6 months +/- 2 weeks
Range of motion
range of motion in the hip joint
Time frame: 1 year +/- 1 month
range of motion
range of motion in the hip joint
Time frame: 2 year +/- 1 month
Metal ions
Crome and cobalt ions in serum and whole blood.
Time frame: Up to two months before surgery
BMD
bone mass density around the implants
Time frame: Within the first week following surgery
RSA
radiostereommetry. Measurement of micromotions (subsidence, rotation and translations)of the implant in relation to the bone
Time frame: Within the first week following surgery
HHS
Harris hip score. An investigator asssesed hip questionnaire including pain, function, deformities and range of motion
Time frame: Up to two months before surgery
UCLA activity
University of California Los Angeles activity score. A score over the intensity of activities the patient engages in.
Time frame: Up to two months before surgery
WOMAC
patient reported outcome of pain, stifness and disability during activities of daily living.
Time frame: Up to two months before surgery
EQ-5d
a short quality of life measure. patient reported
Time frame: Up to two months before surgery
T cell count
quantitative analysis of the level of T-cells in the blood
Time frame: Up to two months before surgery
X-ray
an assesment of the placement of the metal cup. Inclination and anteversion.
Time frame: within 2 years of surgery
steps
using a pedometer 1 week prior to each check up the annual step rate is calculated
Time frame: Up to two months before surgery
sick leave
an assesment of the rehabilitation period following the intervention
Time frame: assesed 6 months following surgery.
Metal ions
Crom and cobalt
Time frame: 8 weeks +/- 1 week
Metal ions
Crome and cobalt
Time frame: 6 months +/- 2 weeks
Metal ions
crome and cobalt
Time frame: 1 year +/- 1 month
metal ions
crome and cobalt
Time frame: 2 year +/- 1 month
BMD
bone mass desity around the implant
Time frame: 8 weeks +/- 1 week
BMD
Bone mass density around the implant
Time frame: 1 year +/- 1 month
BMD
Bone mass density around the implant
Time frame: 2 year +/- 1 month
RSA
Radiostereometry of implant
Time frame: 8 weeks +/- 1 week
RSA
Radiostereometry of implant
Time frame: 6 months +/- 2 weeks
RSA
Radiostereometry of implant
Time frame: 1 year +/- 1 month
RSA
Radiostereometry of implant
Time frame: 2 year +/- 1 month
HHS
Harris hip score
Time frame: 8 weeks +/- 1 week
HHS
Harris hip score
Time frame: 6 months +/- 2 weeks
HHS
Harris hip score
Time frame: 1 year +/- 1 month
HHS
Harris hip score
Time frame: 2 years +/- 1 month
UCLA activity
activity score
Time frame: 8 weeks +/- 1 week
UCLA activity
activity score
Time frame: 6 months +/- 2 weeks
UCLA activity
activity score
Time frame: 1 year +/- 1 month
UCLA activity
activity score
Time frame: 2 years +/- 1 month
WOMAC
self reported function
Time frame: 3 weeks
WOMAC
self reported function
Time frame: 6 weeks
WOMAC
self reported function
Time frame: 8 weeks +/- 1 week
WOMAC
self reported function
Time frame: 6 months +/- 2 weeks
WOMAC
self reported function
Time frame: 1 year +/- 1 month
WOMAC
self reported function
Time frame: 2 years +/- 1 month
EQ-5d
quality of life
Time frame: 8 weeks +/- 1 week
EQ-5d
quality of life
Time frame: 6 months +/- 2 weeks
EQ-5d
quality of life
Time frame: 1 year +/- 1 month
EQ-5d
quality of life
Time frame: 2 years +/- 1 month
T cell count
T cell count
Time frame: 8 weeks +/- 1 week
T cell count
T cell count
Time frame: 6 months +/- 2 weeks
T cell count
T cell count
Time frame: 1 year +/- 1 month
T cell count
T cell count
Time frame: 2 years +/- 1 month
steps
steps measured by pedometer during the week prior to check up
Time frame: 8 weeks +/- 1 week
steps
steps measured by pedometer during the week prior to check up
Time frame: 6 months +/- 2 weeks
steps
steps measured by pedometer during the week prior to check up
Time frame: 1 year +/- 1 month
steps
steps measured by pedometer during the week prior to check up
Time frame: 2 years +/- 1 month
blood loss
blood loss measured in mL
Time frame: during surgery
days in hospital
days in hospital following surgery
Time frame: from admission to discharge from hospital
complications
surgery and implant related complications
Time frame: within the first 2 years following surgery
surgery time
time from skin is incised to skin is closed
Time frame: during surgery
incision length
the length of the surgical incision in cm
Time frame: during surgery
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